Kornimate/medical-research-clean huggingface dataset:
evaluation of hepatic arterial infusion of cisplatin and 5-fu in biomarker stratified hcc

Conditions: Hepatocellular Carcinoma Non-Resectable

Summary: this study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin and 5-fluorouracil (haic) in advanced hcc patients stratified by biomarker expression predicting therapeutic response.

hepatic arterial infusion chemotherapy (haic) with cisplatin and 5-fluorouracil has been used in advanced hcc. however, cisplatin or 5-fluorouracil acts on cells without tumor selectivity. therefore, to improve the tumor selectivity and effectiveness of haic, molecular subtyping-based stratification strategies should be considered. in this study, patients who have progressed or intolerance to sorafenib with non-metastatic hcc in tnm stage iii-iva and ecog ps 0 or 1, child-pugh class a will be enrolled. 96 patients with pre-treatment tumor biopsy will receive cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system. this treatment will be repeated every 4 weeks, up to 6 times. the primary objective is to determine overall response rate, where benefit is defined as complete or partial response according to mrecist v1.1. secondary endpoints include time to progression, progression free survival. the biopsy tissue will be subjected to real time reverse transcriptase polymerase chain reaction for quantification of gene expression levels. patients will be categorized into two groups according to gene expression results, and then auc value of roc curve analysis will be evaluated as an exploratory endpoint to assess predictive performance of biomarker for therapeutic response of haic.

Eligibility criteria:
inclusion criteria: * over 20 years old * patients with advanced hepatocellular carcinoma who have progressed or intolerance to sorafenib * patients with advanced hepatocellular carcinoma who cannot be treated with surgery, transplantation, rfa, or tace. * tnm stage iii/iv (including intrahepatic single or multiple tumors without extrahepatic metastasis regardless of lymph node metastasis) * ecog performance status of 0 or 1 * liver function status of child-pugh class a or b * more than 3 months of life expectancy * serum creatinine \<1.5 mg/dl * aminotransferase \<5 times the upper limit of normal * absolute neutrophil count \>1,500 cells/ll * platelet count \>75,000/ll * hemoglobin \>10 g/dl exclusion criteria: * patients with extrahepatic tumors * patients requiring combined treatment with chemotherapy, radiotherapy, tace, rfa, or others * patients in any severe and/or uncontrolled medical conditions * patients with history of allergic response to ct contrast media * patients who participated as subjects in other interventional clinical studies (as of the date of visit) within 60 days before drug administration * any person deemed inappropriate by reason of the investigator for other reasons
impact of fluid milk on post-meal glycemia and insulinemia in overwt/obese adults

Conditions: Blood Glucose; Blood Insulin

Summary: blood sugar and insulin levels after a meal may be altered by the food and beverages a person consumes. keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and related diseases. this study will look at how drinking different common beverages (milk, low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar and insulin levels.

the broad aim of the proposed research is to evaluate the effects of consuming milk and non-milk beverages with a breakfast meal on postprandial glucose and insulin responses in overweight and obese adults with varying levels of glucose tolerance (normal, pre-diabetic, type 2 diabetes). the investigators expect the consumption of fluid milk with breakfast to decrease the postprandial glucose response relative to other non-milk beverages (orange juice and sweetened coffee). furthermore, the investigators expect that there will be no difference in the postprandial glucose or insulin response between varieties of fluid milk (skim, low-fat, and whole).

Eligibility criteria:
inclusion criteria: * 35-65 years old, * bmi between 27-40 kg/m2, * hba1c less than 7.5%, * weight stable (± 4.5 kg) for the previous 3 months * willing to consume study foods and beverages. exclusion criteria: * using exogenous insulin, * currently (or within the past 6 months) following a vigorous exercise regimen, or weight loss program, * acute illness, * smoking, * pregnant or planning pregnancy in the next 3 months, * lactose intolerant, * weight changes of greater than ± 3 kg during the study period
effects of dietary nitrate in hypertensive pregnant women

Conditions: Hypertension; Pregnancy

Summary: high blood pressure in pregnancy affects around 10% of pregnancies, and is associated with serious adverse outcomes for both mother and baby. treatment options for the management of high blood pressure in pregnancy are currently limited. studies in non-pregnant individuals have shown that supplementation with dietary nitrate, using beetroot juice, can significantly lower blood pressure and improve blood flow. this study aims to investigate whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure regulation in pregnant women with chronic high blood pressure, and will also determine whether this can improve blood flow across the placenta.


Eligibility criteria:
inclusion criteria: * women diagnosed with chronic hypertension (systolic blood pressure of 130-144 mmhg and/or diastolic blood pressure of 80-94 mmhg). * between 22 - 35+6 weeks gestation exclusion criteria: * multi-fetal pregnancy * currently taking anti-hypertensive medication * pre-existing diabetes (type 1 or type 2) * lacking ability to consent
celecoxib for ent pain management

Conditions: Parotidectomy

Summary: the goal of this clinical trial is to find out whether pain can be managed after an operation with celecoxib instead of oxycodone. the main question it aims to answer is if use of celecoxib plus tylenol reduces the need for oxycodone. researchers will compare the combination of celecoxib and tylenol to a placebo to find out whether celecoxib works to manage pain. participants will: * take celecoxib, or a placebo, plus tylenol with opioids as needed * keep a diary of their pain between visits * complete questionnaires

surgeons have a unique opportunity to reduce opioid prescriptions - and therefore potential opioid dependence, morbidity and mortality - by altering prescribing patterns in the perioperative period. this study aims to determine if celecoxib is a viable alternative for acute pain control in the postoperative setting for head and neck surgeries which could significantly reduce the amount of narcotic pain pills in circulation and can be extrapolated to other otolaryngologic procedures.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent document * willing to comply with all study procedures and be available for the duration of the study * ability to take oral medication * undergoing superficial parotidectomy * individuals at least 18 years of age * adequate organ function as indicated by standard laboratory tests: hematology (complete blood count), clinical chemistry exclusion criteria: * history of nsaids contraindication (severe congestive heart failure, cabg within 14 days, arrhythmias, significant coronary artery disease, cardiomyopathy, severe hepatic impairment, history of peptic ulcer disease or gi bleeding, use of anticoagulation (other than prophylactic aspirin) * history of uncontrolled hypertension, cerebrovascular accident, sulfa allergy, allergy to celecoxib * concurrent use of cyp2c9 potentiator/inhibitor * use of investigational drugs, biologics, or devices within 30 days prior to randomization. * individuals who are pregnant, lactating or planning on becoming pregnant during the study. * not suitable for study participation due to other reasons at the discretion of the investigators.
a study to evaluate efficacy and safety of avtx-803 in patients with leukocyte adhesion deficiency type ii

Conditions: Leukocyte Adhesion Deficiency

Summary: the primary objective of this study is to evaluate the efficacy and safety of avtx-803 compared to withdrawal in patients with leukocyte adhesion deficiency, type ii (lad ii).


Eligibility criteria:
inclusion criteria: * subject must be between 6 months and 75 years old * subject has biochemically and genetically proven lad ii (slc35c1-cdg) * subject has a documented history of lewis antigen deficiency * subject has a history of recurrent infections, opportunistic infections or infections that did not respond well to standard of care treatment * subject or parent (for subjects under legal age for consent) has provided written informed consent for this study. additionally, written informed assent has been provided, as appropriate, for minors of older age, per local institutional review board (irb)/ethics committee (ec) policy and requirements * subject is willing and able to comply with the protocol * women of childbearing potential (wocbp) meeting the criteria below: 1. non-lactating and has a negative pregnancy test at screening -and- 2. uses an acceptable double-barrier method of contraception as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug. * male subjects must agree to use an acceptable double-barrier method of contraception with their partner as determined by the investigator or sub-investigator for the duration of the study and 30 days following the last dose of study drug. exclusion criteria: * subject has severe anemia defined as hemoglobin \<8.0 g/dl (\<4.9 mmol/l) * subject has impaired renal function as defined by an egfr \<90 ml/min * subject has a total absence of fucosylation on red blood cells and the presence of anti-h antigen * subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product * in the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing * in the investigator's opinion, subject is not able or not willing to comply with the study requirements. * subject is pregnant
upper extremity selective voluntary motor control in children with unilateral cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of the study was to determine upper extremity selective motor control (smc) in children with unilateral cerebral palsy (cp). it was also aimed to determine the relationship between upper extremity smc and upper extremity functions in unilateral cp.

twenty-four unilateral cp participated in the study between the ages of 6 and 18 years. children's manual skills classified with macs. to assess the quality of the upper extremity, the quality of upper extremity skill test (quest) which assessed four areas including dissociated movement, grasp, weight bearing and protective extension, was used. upper extremity functions were assessed using the jebsen taylor hand function test (jtt). the selective control of upper extremity scale (scues) was used to evaluate the selective movements of the upper extremity. the scues evaluates the movement of the trunk during the upper limb movements and mirror movements via video recording.

Eligibility criteria:
inclusion criteria: * diagnosis of unilateral spastic cp, * age between 5 and 18 years, * ability to follow simple instructions. exclusion criteria: * significant ataxia or dystonia * orthopedic intervention or botulinum toxin injection to the upper extremities in the last 6 months * orthopedic problems or medical conditions that prevented children from participating in the assessment

Keywords: cerebral palsy upper extremity selective motor control
registry of long-term antithrombotic therapy-2

Conditions: Atrial Fibrillation

Summary: to assess the rates of ischemic and hemorrhagic complications of long-term antithrombotic therapy in patients with atrial fibrillation

the register is a russian prospective single-center observational study of patients who have indications for long-term antithrombotic therapy in connection with atrial fibrillation

Eligibility criteria:
inclusion criteria: * documented atrial fibrillation with cha2ds2vasc \> 1 exclusion criteria: * subjects who are unwilling or unable to provide informed consent. acs within 12 months before inclusion severe chf (nyha iv) stroke within 6 months before inclusion severe liver or muscle disease severe kidney disease / renal failure with creatinine \> 3 mg/dl conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention

Keywords: atrial fibrillation, coronary artery disease
a phase 1,open -label study to assess the absorption, metabolism and excretion of 14c-ops-2071 following a single oral dose to healthy male japanese subjects

Conditions: Bacterial Enteritis

Summary: to obtain absorption, metabolism and excretion data for parent drug and any metabolites.


Eligibility criteria:
inclusion criteria: * healthy males * body mass index (bmi) between 18.5 and 25.0 kg/m2, inclusive * subjects will have given their written informed consent to participate in the study and to abide by the study restrictions exclusion criteria: * subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the investigator. * subjects who smoke, or who have used nicotine within 3 months prior to screening.. * subjects who have a significant history of drug allergy, as determined by the investigator. * subjects who have any clinically significant abnormal physical examination finding. * subjects who have any clinically significant medical history, as determined by the investigator. * subjects who are exposed to radiation as a result of their occupation. * subjects who have had an x ray or ct scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
a default option for health: improving nutrition within the financial and geographic constraints of food insecurity

Conditions: Food Selection; Obesity

Summary: food insecurity is associated with an increased risk of obesity. the availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. an online default option (i.e., prefilled grocery shopping cart) was previously shown to positively impact the food purchases of individuals with food insecurity.the present study aims to extend these findings bye examining efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity over the course of a month.

food insecurity is associated with an increased risk of obesity and weight-related illnesses. the present study is the first longitudinal randomized control trial to examine if an online prefilled grocery shopping cart (i.e., a default cart) nudges individuals with food insecurity to purchase healthier groceries compared to receiving nutrition education. it was hypothesized that the prefilled online grocery shopping cart (i.e., default condition) will result in a significant improvement in the nutritional quality of groceries purchased compared to those receiving nutrition education. thirty-eight food pantry users recruited from food pantries in new york in 2018 were enrolled in the present study and were given $48.50 to purchase groceries weekly using an online grocery website for five weeks. at baseline, participants were instructed to purchase groceries keeping in mind nutrition, cost, and taste. for the subsequent four weeks (t1-t4), participants were randomized to receive 1) nutrition education or 2) a prefilled online grocery shopping cart that met their nutritional needs based on age and sex (default). our primary nutritional outcomes included hei scores, calories (kcal), and energy density (kcal/grams).

Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. residing in a single person household 3. receiving assistance at a food pantry 4. able to read and write in english 5. able to provide informed consent 6. current residence in a zip code served by price chopper's delivery program 7. none of the following dietary restrictions: vegetarian/vegan, gluten-free/celiacs, lactose intolerance, egg allergy

Keywords: food insecurity nutrition obesity default option online grocery shopping
solid-effect of risedronate sodium at distal radius in colle's fracture.

Conditions: Colles' Fracture

Summary: the purpose of this study is to evaluate the efficacy and safety of risedronate sodium (actonel®) after a wrist fracture in postmenopausal women.


Eligibility criteria:
inclusion criteria: * women with description of 2 or more years of menopause; * t-score \<= -2.0 sd; * confirmed colles'fracture; * independent for the march (preserved ambulatorial ability); exclusion criteria: * co-morbidities; * regular use of corticosteroids or other anti-resorptive drug in the last year; * use of drugs that can affect the calcium metabolism; * hypersensitivity to risedronate; * previous wrist or forearm fracture; * hypocalcemia; * renal insufficiency; * rheumatic disease; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
structured education program and glycemic control in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes (T1D); Type 1 Diabetes Mellitus (T1DM)

Summary: type 1 diabetes is becoming more common in kuwaiti and arab adolescents. many young people with this condition struggle to keep their blood glucose levels under control, which can lead to diabetes-related complications and affect their quality of life. the goal of this clinical trial is to evaluate the effectiveness of a structured educational program on glycemic control among arab adolescents with type 1 diabetes aged 11 to 14 years. participants will be randomly assigned to one of two groups. the intervention group will receive the structured education program, and the control group will continue with standard care. all participants will undergo assessments that include: * collecting demographic and diabetes management data * measuring weight and height * measuring hba1c levels and lipid profile * filling out questionnaires on quality of life, carbohydrate and insulin dosing knowledge, physical activity * collecting dietary intake * providing agp report participants in the intervention group will additionally be required to: * attend the program for 4 consecutive days, one day for parents and three days for children * fill out 3-day food diary records during the program * attend a refresher course after 6 months participants in the control group will have the opportunity to participate in the program after approximately six months.


Eligibility criteria:
inclusion criteria: * arab adolescents * males and females aged 11 to 14 years. * have been diagnosed with type 1 diabetes for at least 6 months. * wearing a continuous glucose monitor (cgm). * individuals and their parents must be able to join the entire duration of the study. * individuals and their parents must voluntarily provide consent and assent. exclusion criteria: * presence of learning disabilities or any known psychological issues. * attendance at any diabetes education or carbohydrate counting programs within the six months preceding the study.

Keywords: kuwait glycemic control type 1 diabetes carbohydrate counting arab adolescents structured education adolescents diabetes education program hba1c
phase 1 safety and tolerability study of msk-da01 cell therapy for advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: this clinical trial is designed to test whether surgically injecting nerve cells that make dopamine into the brain of parkinson's disease patients is safe, and to monitor for potential side effects.

subjects will undergo surgical transplantation of the dopamine-producing cells under general anesthesia into a part of the brain called the putamen. subjects then take medicines to partially suppress their immune system (aimed to prevent the body from rejecting the cells) for 1 year. safety, tolerability, evidence of cell survival (using mri and pet scans of the brain), and effect on parkinson's disease symptoms are assessed for 2 years post-transplant.

Eligibility criteria:
inclusion criteria: * age 50-78 years old (canada) * age 60-78 years old (united states) * diagnosis of parkinson's disease made between 3 to 20 years ago * taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia * able to participate in all study visits and evaluations, including brain mri and pet scan * existence of a study partner who may act as potential surrogate over long term for ongoing consent exclusion criteria: * diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as alzheimer's disease * prior deep brain stimulation , lesion therapy, or gene therapy for pd * prior surgical or radiation therapy to the brain or spinal cord * any medical condition resulting in high risk of immunosuppressive drugs, including any active infectious disease * inability to temporarily stop anti-platelet agents or other anti-coagulant medications without serious risk * previous or currently active malignant disease within the past 5 years, except basal cell carcinoma or in situ uterine cervical carcinoma that have been treated * severe obesity (\>350 lbs) or any condition that prevents use of pet/mri * pregnancy or breastfeeding * contraindication to surgery or general anesthesia * in the opinion of the investigator, any other condition regarded as making subject unsuitable for trial
a phase ii trial of ofatumumab in subjects with waldenstrom's macroglobulinemia

Conditions: Waldenstrom Macroglobulinaemia

Summary: given the tolerability and efficacy of ofatumumab in follicular lymphoma and chronic lymphocytic leukemia, and the need to improve therapy for patients with wm utilizing a non-myelosuppressive agent this phase ii trial of ofatumumab is being initiated in patients with waldenstrom's macroglobulinemia (wm).


Eligibility criteria:
inclusion criteria: * confirmed and active waldenstrom's macroglobulinemia requiring treatment. * ambulatory and capable of all selfcare. up and about more than 50% of waking hours. * adequate organ function. * detectable cd20 positive of the tumor cells. * measurable disease as defined by a monoclonal igm paraprotein level greater than 1000 mg/dl. exclusion criteria: * treatment of wm within the past 28 days. * treatment with rituximab or alemtuzamab within the past 3 months. * certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years. * current participation in another interventional clinical study. * lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception. * active cerebrovascular disease.

Keywords: waldenstrom's macroglobulinemia ofatumumab